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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT VIAL ACCESS CANNULA; CANNULA, SURGICAL, GENERAL PLASTIC SURGERY

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CARDINAL HEALTH, INC. MONOJECT VIAL ACCESS CANNULA; CANNULA, SURGICAL, GENERAL PLASTIC SURGERY Back to Search Results
Model Number 8881540133
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 03/12/2021
Event Type  malfunction  
Event Description
When rn was drawing up medication from vial to syringe, the vial access cannula had a small hole in the side and medication was squirting out of it.Resulting in wasted medication.Vial and medication had to be wasted and a new vial was utilized.
 
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Brand Name
MONOJECT VIAL ACCESS CANNULA
Type of Device
CANNULA, SURGICAL, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
15 hampshire street
mansfield MA 02048
MDR Report Key11588278
MDR Text Key242992969
Report Number11588278
Device Sequence Number1
Product Code GEA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8881540133
Device Catalogue Number8881540133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2021
Event Location Other
Date Report to Manufacturer03/30/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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